This invention relates to a device in the form of a tracheal cannula or prosthesis for restoring the voice, to be inserted into a tracheostoma,
Tracheostoma prostheses (also known as tracheal cannulas or tracheostoma tubes) for treating patients without larynx (laryngectomees) with opened throat (so called tracheostoma) have been known for decades.
Apart from mere tracheal cannulas, for example for ventilating a patient via an opening below the larynx, a prosthesis can be used according to s the prior art to generate a new voice at patients with removed larynx, and said voice prosthesis (tracheostoma tube with speaking valve) creates a more or less permanent passage into the oesophagus while air, following its natural flow path, moves from the lung through a tracheostoma to the outside, Thus, the so called esophageal speaking is produced.
The tracheostoma tubes with a speaking valve mostly consist of a treacheal cannula with cannula shield and a valve receiving part for holding an external speaking valve, whereas an internal speaking valve of the tracheal cannula is accommodated in a tube between the oesophagus and the trachea so that air can escape through the internal speaking valve towards the mouth area if the tracheostoma is blocked (in case of a closed external speaking valve) and vibrations are generated for the purpose of speaking in the upper area of the oesophagus. In these arrangements, the tracheostoma is blocked manually by closing the external speaking valve at the outer surface of the tracheal cannula.
These tracheostoma cannulas mostly comprise flexible retaining collars. If properly applied, the retaining collar fits closely to the oesophagus facing surface of the party wall between the trachea and the oesophagus to avoid or at least reduce the likelihood of a dislocation of the prosthesis in the tracheostoma,
Thus, said retaining collar considerably improves the support of the prosthesis (for example provides protection against the ejection of the prosthesis) but this arrangement has the disadvantage that a big retaining collar makes the insertion of a prosthesis more difficult because the tissue surrounding the tracheostoma is traumatized.
From EP 1 099 451 A3 the use of conical tips is principally known in tracheostomy.
DE 10 2005 021 470 A1 discloses an insertion aid for the percutaneous tracheostomy that comprises a shaft with a conical tip being threadable through the tracheal cannula, and said tip has a small basic diameter in a is first state and a large basic diameter in a second state, and the insertion aid has a section adjacent to the conical tip with a maximum diameter corresponding to the inner diameter of a tracheal cannula to be introduced by means of the insertion aid.
DE 694 32 755 T2 discloses a plastic insertion aid that is designed for use in tracheostomy and is provided with flexible bend sections between single noses to improve its operability.
WO87/06817 describes a prosthesis for use in sinus drainage that is provided with flexible wings that can be folded to move the prosthesis along a body channel.
DE 20 2010 002 803 U1 discloses a device for the introduction of a tracheal cannula into a tracheostoma by using an insertion aid (inserter) the tip of which being firmly bonded to a paraglider which lays on the cannula tube edge with a cover width when the insertion aid is moved into the trachal cannula tube.
DE 693 17 445 T2 discloses a device for the insertion of a prosthesis in a hole between the trachea and the esophagus (tracheostoma) to restore the voice, and said device comprises a cylindrical body having a longitudinal axis, a flexible flange which is provided on an outer surface of the device body and has a direction of use in which it extends essentially from the outer surface of the device body to the outside and has a direction of use in which it is folded flexibly towards the longitudinal axis of the device body, as well as an insertion aid having a means (e.g., gelatin capsule) for retaining the flange in its flexibly folded orientation, and said retaining means is made of a material (e.g, gelatin) that is dissoluble in the liquid existing between the esophagus and the trachea.
This device has the disadvantage that the substances being dissoluble in liquids (e.g, gelatin capsules) provoke irritations or immune reactions in the patient because they are exogenous substances or the capsules (e.g. gelatin capsules) do not dissolve completely so that the patient needs very much force to achieve an air stream through the prosthesis for the esophageal speaking.